European Commission – Press release

Medical devices: European Commission asks for further scientific study and draws first lessons from the recent fraud on breast implants

Brussels, 2 February 2012 – Following today’s publication of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) on the safety of silicone products manufactured by the Poly Implant Prothèse (PIP) Company, the European Commission requested to conduct further in-depth study on the potential health impact of faulty breast implants.

The Commission will also discuss with the Member States how surveillance of the medical devices can already be reinforced immediately within the existing legislative framework. In parallel a “stress test” of the legislation on medical devices is under way in order to identify how best the questions raised by this issue can be addressed in the revision of this framework already foreseen for 2012.

Health and Consumers Commissioner, John Dalli said: “In the current situation, patients’ health remains the priority. The opinion published today sums up the current scientific knowledge on this case”. To add : “Furthermore, the Commission will discuss with the Member States a series of immediate measures to strengthen the existing surveillance and safety controls on medical devices already on the market. The capacity to detect and minimize the risk of fraud must be increased”. To conclude : “We had already been working on a revision of the Medical Devices Directive, envisaged for adoption  this spring.  We will now also take into account the lessons learnt from this case and take them on board in redrafting our legislation, in particular with regard to market surveillance, vigilance and functioning of notified bodies.”

Scientists concluded that data available today was insufficient to lead to firm conclusions regarding the health risk for women with PIP silicone breast implants.

The SCENIHR report (requested by the Commission in early January) stresses that, based on the limited data currently available, there is some concern regarding the possibility of inflammation induced by ruptured PIP silicone implants. The report concludes that each case needs to be assessed individually, so the advice remains that women who are worried should contact their surgeon.

Scientists also recommend that further work be undertaken as a priority to establish with greater certainty any health risks associated with PIP silicone breast implants, in order to ensure that potential risks are properly established, quantified and managed.

With regard to the question of whether the breast implants manufactured by PIP are more prone to failure than those of other manufacturers, SCENIHR said that PIP implants have been found to vary considerably in composition and as a result are likely to vary substantially in performance characteristics.

SCENIHR concluded on the basis of available data, that many PIP implants were manufactured from non-medical grade silicone. This type of silicone may contain some components that can weaken the implant shell and diffuse into the body tissues.

Next steps

First, the European Commission will ask the Scientific Committee to pursue a more in-depth investigation based on data from investigations by Member States.

Second, the Commission will discuss with the Member States how surveillance of the medical devices can be reinforced immediately within the existing legislative framework. These issues could include further recourse to unannounced inspections, enhanced controls of notified bodies and additional sample testing on products already on the market.

Third, the Commission is also conducting a stress test in order to identify how best the questions raised by this issue can be addressed in the upcoming revision of the legislation on medical devices which was already underway. The Commission still envisages adopting a proposal on the revision of the Medical Devices legislation in the course of this semester.

National health authorities in the Health Security Committee convene by audio conference today to discuss the follow up to the Opinion.

Background

Breast implants fall under the European legislation on medical devices1. This legislation requires that, before placing such devices on the market, the manufacturers must carry out an assessment to ensure that their devices fulfil the relevant legal requirements, and in particular that their devices will not compromise patient safety. For high risk devices, such as breast implants, a third party conformity assessment body, so-called notified body, is involved in the conformity assessment procedure.

In the present case, an investigation triggered by an unusually high short-term breast implant rupture rate has shown that a manufacturer (Poly Implant Prothèse Company) fraudulently made use of industrial silicone instead of the approved medical grade silicone. The product was withdrawn from the EU market in 2010.

On the basis of available data, it is estimated that around 400 000 PIP silicone breast implants were sold worldwide. These implants were available in nearly all European Union Member States – in particular they were widely used in the United-Kingdom, France, Spain and Germany, where respectively around 40.000, 30.000, 10.000 and 7.500 women were implanted with PIP silicone breast implants.

Work of the SCENIHR

SCENIHR is an independent advisory body established by the Commission. Its members are chosen on the basis of scientific excellence and they advise the Commission on issues associated with new and emerging health risks.

The current rapid opinion drew on top international scientists’ expertise in fields of plastic surgery, polymer science, senology and medical epidemiology.

To see the full scientific opinion on the safety of PIP breast implants, see

http://ec.europa.eu/health/scientific_committees/emerging/index_en.htm

Link to Medical Devices Directive:

http://ec.europa.eu/health/medical-devices/regulatory-framework/index_en.htm

1 :
OJ L 169, 12.7.1993, p. 1

This document refers to the EU Directive on accreditation and market surveillance relating to the marketing of products which is EC/765/2008.  EC/765/2008 is relied on for the term “making available’.

The interpretative document may be viewed by clicking EU Interpretative Document – Placing Medical Devices on the Market.

To see a list of the current EU Medical Device Directives Interpretative Documents you can go to the EUROPA webpage that has the Medical Device Directives Interpretative Documents.

Download all our newsletters at http://www.EisnerSafety.com/esc-news/

Summary:
This issue is packed full of important updates and useful information. First, we are going to focus on additional updates with regard to IEC/EN 60601-1:2005/2006 as there is significant news since the last issue of our newsletter.

Next we delve into the MDD Amendment 2007/47/EC specifically on the updated Classification MEDDEV and the new Clinical Data requirements. We also would like to remind you when your EU MDD Notified Body is up to reviewing your technical file or design dossier you need to make sure you have addressed the Usability and Clinical Data requirements as they apply to all medical devices under the MDD Amendments. If you need help with these new requirements to the MDD we have a toolkit that will be helpful to you.

Lastly, our Associate Christine Ruther writes about an FCC publication in regard to medical devices that use inductive coupling to recharge batteries.

We hope you enjoy this edition of the newsletter and we would enjoy hearing back from you on any suggested topics and your feedback.

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This issue we are going to focus on primarily on IEC/EN 60601-1:2005/2006 as there is some significant news within the last few weeks and more to come really soon.  Also, we would be remiss if we didn’t remind you that the MDD Amendment 2007/47/EC becomes mandatory this weekend on March 21, 2010.  There is no transition period for the amendment to the MDD.

First, we are presenting an audio conference titled “Is Your Product Development Cycle Ready for IEC 60601-1 3rd Edition?” which will be on March 25^th.  Please come and join in the audio conference.  See below for a special discount code that only Eisner Safety Consultants is able to provide to you.  Next we want to remind you about the MDD Amendment deadline and that we can help you out with our MDD Amendment Toolkit, which is only $249.00.  Our third article summarizes the recent important information related to 60601-1, 3^rd ed. and related standards.  This is a must read especially the part with the FDA.  Lastly, we let you know that there are 3 different ways to get up to date notices from Eisner Safety Consultants (ESC Updates) on the medical device industry regulatory, product safety and quality system news.

If you have any questions regarding any of the subjects of this newsletter please feel free to contact us.  We hope you enjoy our fifth newsletter and we would enjoy hearing back from you on any suggested topics and your feedback.

To see past editions of the newsletter go to www.EisnerSafety.com/esc-news/. Subscribe to the newsletter to get future newsletters.  Go to any page on the website and enter your e-mail address in the upper left side of the webpage where it says “Sign-Up to our Newsletter”.

In our newsletter of 2 July 2009 we revised this statement and explained that not all declarations of conformity might have to be re-issued in general.

Subsequent discussions with several authorities and Notified Bodies revealed that the issue of new declarations of conformity has not yet been discussed clearly and uniformly across all EU Member States and that therefore the statements of the individual Member States on this subject also differ. While some EU Member States consider the issue of new declarations of conformity as unavoidable in general, other EU Member States consider internal evidence of compliance to be sufficient.However, not only the European authorities, but other stakeholders too are interested in a declaration of conformity; they include hospital purchasing departments, registered practitioners and non-EU authorities.
Given this, we expect further discussions between authorities, manufacturers and Notified Bodies on the issue of new declarations of conformity. The cases in which no new declaration of conformity has been issued, may require increasing coordination and agreement between manufacturers and clients and/or authorities and/or suppliers or sub-contractors in the future.

In view of the fact that by 21 March 2010 many harmonized standards will lose their status as evidence of compliance with the essential requirements, we can only advise manufacturers at present to consider whether it may not be more sensible to issue a new declaration of conformity in order to keep all further discussions, phone conversations and correspondence to a minimum.

All declarations of conformity which are issued before 21 March 2010 and which are to document evidence of compliance with 2007/47/EC must include reference to 2007/47/EC. Such reference may be omitted in declarations of conformity issued after 21 March 2010, as Directive 2007/47/EC applies as a matter of principle and other options are no longer available.

Compliance with the essential requirements of the medical devices directive no longer ensured

Harmonized standards are published in the Official Journal of the European Union. Medical devices complying with the requirements of the standards listed in these publications may be assumed to comply with the essential requirements of the Medical Devices Directive.

Through this newsletter, we would like to draw your attention to the fact that many of these harmonized standards will become invalid by 21 March 2010 and will be replaced by new standards. Given this, these standards may no longer be used to assume compliance with the essential requirements of the Directive.

Please review the documentation of your medical devices to ensure that compliance with the essential requirements of the Medical Devices Directive is still maintained with the new editions of the harmonized standards. To continue to assume the compliance with the essential requirements of the Directive, revised or new requirements of these harmonized standards may have to be fulfilled.

The list of harmonized standards for general medical devices as per Directive 93/42/EEC can be found on the following web site:

http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/medical-devices/index_en.htm

The list of harmonized standards for active implantable medical devices as per Directive 90/385/EEC can be found on the following web site:

http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/implantable-medical-devices/index_en.htm

Disclaimer: This is a voluntary service provided by TÜV SÜD Product Service GmbH. While we analyse and interpret the relevant information very thoroughly, we accept no responsibility for the correctness of the information provided. Changes in the content of the interpretation on the part of the authorities are possible at any time.

This issue we are going to focus on primarily on the MDD Amendment 2007/47/EC as the deadline to comply is very soon.  You must comply with the MDD Amendment 2007/47/EC as of March 21, 2010.  There is no transition period for the amendment to the MDD.  First, we are presenting an audio conference titled “Are You Ready for the MDD Amendment Directive 2007/47/EC” which will be on January 25^th.  Please come and join in the audio conference.  See below for a special discount code that only Eisner Safety Consultants is able to provide to you.  Next we provide you with updated MEDDEV Guidance documents that have been updated to align with the Amendment to the MDD.  In addition to the above items to help you out you can also purchase our MDD Amendment Toolkit, which is only $249.00.

We will occasionally provide you with an Associate Profile so you can get to know some of our varied staff and some of their experience.  This edition we feature our newest Associate, Alf Dolan.

If you have any questions regarding any of the subjects of this newsletter please feel free to contact us.  We hope you enjoy our fourth newsletter and we would enjoy hearing back from you on any suggested topics and your feedback.

To see past editions of the newsletter go to www.EisnerSafety.com/esc-news/. Subscribe to the newsletter to get future newsletters.  Go to any page on the website and enter your e-mail address in the upper left side of the webpage where it says “Sign-Up to our Newsletter”.

Are You Ready for MDD Amendment Directive 2007/47/EC?

Wednesday Jan 27, 2010, 2:00pm – 3:00pm Eastern Time, 60 minutes

Get a $50 discount ($199 after discount) for this event by using the special promotion code AF2009EIS when you sign up at the FX conferences website

Audio conference highlights

Time is running out – ease your MDD compliance strategy stress with detailed guidance from Leo Eisner!

The revised MDD 93/42/EEC comes into effect on March 21, 2010 and the changes will impact all medical device manufacturers that CE mark their products or plan to do so in future. There is no transition date for the amendment 2007/47/EC and if you are not in line with these new requirements by the implementation date, you could lose your CE mark certificate from your notified body.

In this audio conference, Leo Eisner provides an overview of the changes to the MDD, including: changes to definitions, the essential requirements, technical documentation requirements, classification rules, labeling requirements, and new requirements for usability (user error) and clinical data. The presentation also covers how the New Machinery Directive and the Personal Protective Device Directive work in concert with the MDD Amendment.

This audio conference covers:

• Major areas of change in the amended Medical Device Directive
• The drivers for this change
• Things your notified body may ask for during an audit
• Determining what areas of your system may be impacted
• The interplay between the revised MDD and other EU directives

Who should attend?

• Regulatory Affairs
• Quality Assurance
• Operations/Manufacturing
• Managing Directors
• Senior Management

Sign-up for the audio conference right here and use promo code AF2009EIS for a $50 discount on this event only

This issue we are going to focus on the 60601-1 series of standards based on the 3^rd edition of 60601-1 and the MDD & AIMDD, including the Amendment 2007/47/EC for the MDD.  First we are presenting an audio conference on the Marking and Labeling requirements for IEC 60601-1 which will be on November 18^th.  Please come and join in the audio conference.  Next we summarize the issues discussed on the CENELEC FAQ web page dealing with EN 60601-1, 3^rdedition questions that apply to the MDD and AIMDD.  Then we discuss the big changes coming down the line for the draft EMC Standards IEC 60601-1-2, 4^th edition & the new IEC 6XXXX, 1^stedition.  This is a must read article for any electrical medical device manufacturer.  Lastly, we remind you that there are less than 5 months left til the MDD Amendment requirements come into play.  One way to deal with this is to use our MDD Amendment Toolkit, which is only $249.00.

We hope you enjoy the third edition of our newsletter and we would enjoy hearing back from you on any suggested topics and your feedback.

To see past editions of the newsletter go to www.EisnerSafety.com/esc-news/. Subscribe to the newsletter to get future newsletters.  Go to any page on the website and enter your e-mail address in the upper left side of the webpage where it says “Sign-Up to our Newsletter”.

This issue we are focusing on the MDD Amendment 2007/47/EC including our toolkit to make your transition much easier and an interpretative EC guidance on the implementation of 2007/47/EC.  These are both great resources to use to get you thru this transition.  Also, we will focus on EU vigilance reporting per MEDDEV 2.12-1, revision 5 and record retention requirements per ISO 13485, ISO 9000, MDD, AIMDD, & IVD.  These last two topics are good reminders to check your quality system procedures, forms, and records to ensure you are meeting the proper requirements prior to your next audit by a registrar or EU Notified Body.

We hope you enjoy this edition of the newsletter and we would enjoy hearing back from you on any suggested topics and your feedback.

To see past editions of the newsletter go to www.EisnerSafety.com/esc-news/. Subscribe to the newsletter to get future newsletters.  Go to any page on the website and enter your e-mail address in the upper left side of the webpage where it says “Sign-Up to our Newsletter”.

This newsletter contains articles on IEC 60601-1, 3rd ed (published in MD&DI – Sept ’09), The Amendment to the Medical Device Directive, Pre-Announcement of our Gap Analysis & Update Package for the MDD Amendment 2007/47/EC, our Standards & Regulations Update Service, announcement of the Medical Device Track at the Oct ’09 IEEE Product Safety Engineering Society, and on the launch of Eisner Safety Consultants New Website.

Subscribe to the newsletter to get future newsletters.  Go to any page on the website www.EisnerSafety.com and enter your e-mail address in the upper left side of the webpage where it says “Sign-Up to our Newsletter”.